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Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

Primary Purpose

Lung Cancer, Gastro-Intestinal Cancer, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
physical exercise
nutrition counseling
whey protein supplement
Sponsored by
Kantonsspital Winterthur KSW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring palliative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Advanced cancer patients not eligible for curative treatment: lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural mesothelioma, urothelium carcinoma, renal cell carcinoma
  • WHO performance status ≥ 2
  • Able to walk independently at least 100 meters
  • Estimated life expectancy of ≥ 6 month

Exclusion Criteria:

  • Patients currently using nutritional supplements with branched chain amino acids
  • Enteral or parenteral nutrition within 1 month
  • History of ileus within 1 month
  • Psychiatric disorder precluding understanding of information on trials related topics and giving informed consent
  • Milk protein allergy

Sites / Locations

  • Kantonsspital Winterthur

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks

Participants will receive standard care

Outcomes

Primary Outcome Measures

Change in physical performance
Physical performance will be assessed with the short physical performance battery

Secondary Outcome Measures

Change in body composition
Body composition will be assessed with bioimpedance
Change in quality of life
Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30
Change in fatigue
Fatigue will be assessed with the questionnaire brief fatigue inventory
Change in physical function
Physical function will be assessed with 60s-sit-to-stand-test and timed-up&go-test
Change in nutritional status
Nutritional status will be assessed with hand grip, nutritional risk screening 2002 and patient-generated subjective global assessment
Change in diet history
3-day food records brought in at weeks 0, 12 and 24 will be analyzed for energy- and protein intakes
Number of re-hospitalization
Number of re-hospitalization
Change in WHO performance status
Change in WHO performance status
Overall survival
Overall survival

Full Information

First Posted
October 13, 2015
Last Updated
January 10, 2019
Sponsor
Kantonsspital Winterthur KSW
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1. Study Identification

Unique Protocol Identification Number
NCT02585362
Brief Title
Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program
Official Title
Influence of a Specially Formulated Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program on Physical Performance in Cancer Outpatients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Winterthur KSW

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates physical performance in cancer outpatients during a multimodal therapy. Half of the patients will receive physical exercise und nutrition program in combination with a specially formulated whey protein supplement, while the other half will receive standard care.
Detailed Description
The time period of Intervention will last 3 month, measurements will be conducted at baseline and 3 month. After 6 month there will be an additional follow-up test point to assess the sustainability of the intervention. The 3-month intervention study consists of a physical exercise program and nutrition counseling in combination with a specially formulated whey protein supplement high in leucine. The standardized training program will be performed twice a week in the physical department of the Kantonsspital Winterthur (KSW) and once a week in a home based setting. Additionally, participants of the intervention group will be aks to consume 15 g of the nutrient supplement powder with approximately 150 ml water. On workout days the supplement should be taken twice a day and on the remaining days once a day. During the three month intervention study participants will take part in a nutrition counseling for at least three times.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Gastro-Intestinal Cancer, Breast Cancer, Prostate Cancer, Pleural Mesothelioma, Urothelial Carcinoma, Renal Cell Carcinoma, Ovarian Cancer
Keywords
palliative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Participants will receive physical exercise, nutrition counseling and a whey protein Supplement over 12 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will receive standard care
Intervention Type
Behavioral
Intervention Name(s)
physical exercise
Intervention Description
The standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting
Intervention Type
Behavioral
Intervention Name(s)
nutrition counseling
Intervention Description
At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake
Intervention Type
Dietary Supplement
Intervention Name(s)
whey protein supplement
Intervention Description
On workout days study participants will consume twice a day 15 g of the supplement powder with approximately 150 ml water. On the remaining days participants consume the supplement once a day.
Primary Outcome Measure Information:
Title
Change in physical performance
Description
Physical performance will be assessed with the short physical performance battery
Time Frame
measured at week 0, 12 and 24
Secondary Outcome Measure Information:
Title
Change in body composition
Description
Body composition will be assessed with bioimpedance
Time Frame
measured at week 0, 12 and 24
Title
Change in quality of life
Description
Quality of life will be assessed with the questerionnaire EORTC-QLQ-C30
Time Frame
measured at week 0, 12 and 24
Title
Change in fatigue
Description
Fatigue will be assessed with the questionnaire brief fatigue inventory
Time Frame
measured at week 0, 12 and 24
Title
Change in physical function
Description
Physical function will be assessed with 60s-sit-to-stand-test and timed-up&go-test
Time Frame
measured at week 0, 12 and 24
Title
Change in nutritional status
Description
Nutritional status will be assessed with hand grip, nutritional risk screening 2002 and patient-generated subjective global assessment
Time Frame
measured at week 0, 12 and 24
Title
Change in diet history
Description
3-day food records brought in at weeks 0, 12 and 24 will be analyzed for energy- and protein intakes
Time Frame
measured at week 0, 12 and 24
Title
Number of re-hospitalization
Description
Number of re-hospitalization
Time Frame
up to 24 weeks
Title
Change in WHO performance status
Description
Change in WHO performance status
Time Frame
measured at week 0, 12 and 24
Title
Overall survival
Description
Overall survival
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced cancer patients not eligible for curative treatment: lung cancer, gastrointestinal cancer, breast cancer, prostate cancer, ovarian cancer, pleural mesothelioma, urothelium carcinoma, renal cell carcinoma WHO performance status ≥ 2 Able to walk independently at least 100 meters Estimated life expectancy of ≥ 6 month Exclusion Criteria: Patients currently using nutritional supplements with branched chain amino acids Enteral or parenteral nutrition within 1 month History of ileus within 1 month Psychiatric disorder precluding understanding of information on trials related topics and giving informed consent Milk protein allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miklos Pless, Prof.
Organizational Affiliation
Kantonsspital Winterthur KSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Whey Protein Supplement in Combination With Physical Exercise and Nutrition Program

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